Steno Tech Explore: A Multisite Exploratory Study of People With Type 1 Diabetes on Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 770
- 试验地点
- 2
- 主要终点
- Glycated Hemoglobin A1c (HbA1c)
研究概览
简要总结
The present study is part of an overarching study being conducted in Denmark at Steno Diabetes Center Copenhagen (SDCC) and Nordsjællands Hospital Hillerød (NOH), Steno Tech, that aims to develop and ultimately, in a randomized controlled trial (RCT), test approaches that can assist people with type 1 diabetes in obtaining optimal outcomes using CSII. Through a large-scale, questionnaire-based online survey enriched with data from national registers, this sub-study contributes to this overarching aim by exploring the importance of individual differences across a wide range of factors, including demographic, socioeconomic, health status, psychosocial and preference structures, for optimal use of CSII in people with type 1 diabetes.
详细描述
See attached protocol for a detailed description.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Glycated Hemoglobin A1c (HbA1c)
时间窗: 13 years (from 2008 (beginning of register) to present)
Information on HbA1c in mmol/mol will be extracted from national registers
次要结局
- General diabetes and insulin pump-specific behavior(1 day (measured at one time point only, i.e., at the survey completion date for each participant))
- Diabetes distress(1 day (measured at one time point only, i.e., at the survey completion date for each participant))
- Hypoglycemia anxiety(1 day (measured at one time point only, i.e., at the survey completion date for each participant))
- Technology-specific satisfaction(1 day (measured at one time point only, i.e., at the survey completion date for each participant))
- Other diabetes-relevant biomarkers(13 years (from 2008 (beginning of register) to present))
- Psychological well-being(1 day (measured at one time point only, i.e., at the survey completion date for each participant))
- Educational, time and risk preferences(1 day (measured at one time point only, i.e., at the survey completion date for each participant))
研究者
Signe Schmidt
MD, PhD, Researcher
Steno Diabetes Center Copenhagen